Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

Device Description

Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).

AI/ML Overview

The provided text describes a medical device (Chairside® Attachment Processing Material) seeking 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving they are met through a dedicated study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance metric acceptance criteria in the way typically seen for a new or significantly modified device where extensive clinical or standalone performance studies against predefined targets are conducted.

Instead, the submission demonstrates "substantial equivalence" to predicate devices based on:

Similarities in Usage and Design: The device has the same intended use, operating principle, basic design, similar materials, and packaging as predicate devices.
Performance Testing against Standards: Non-clinical data, specifically performance testing, was conducted following established ISO standards (ISO 20795-1 and ISO 4049) relevant to dental materials. This testing aims to show that the device performs similarly to or within the acceptable range for such materials, as represented by the predicates.

Here's a breakdown of the requested information based on the provided text, with explicit notes where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Target)	Reported Device Performance (Chairside® Attachment Processing Material)
Flexural strength per ISO 20795-1	Not explicitly stated. The document indicates this test was performed but does not provide the specific performance outcome or the target values for acceptance. It's implied that the results were within acceptable limits for substantial equivalence to predicates.
Flexural modulus per ISO 20795-1	Not explicitly stated. The document indicates this test was performed but does not provide the specific performance outcome or the target values for acceptance. It's implied that the results were within acceptable limits for substantial equivalence to predicates.
Water Sorption per ISO 4049	Not explicitly stated. The document indicates this test was performed but does not provide the specific performance outcome or the target values for acceptance. It's implied that the results were within acceptable limits for substantial equivalence to predicates.
Water Solubility per ISO 4049	Not explicitly stated. The document indicates this test was performed but does not provide the specific performance outcome or the target values for acceptance. It's implied that the results were within acceptable limits for substantial equivalence to predicates.

Note: The document only states that these tests were performed and that the data "demonstrates substantial equivalence." It does not provide the specific numerical acceptance criteria for each test or the exact performance results of the Chairside® Attachment Processing Material against those criteria. This level of detail is often found in the full 510(k) submission, not typically in the summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "non-clinical data" and "performance testing" based on ISO standards. These standards prescribe sample sizes, but the specific number of samples tested for each property (flexural strength, water sorption, etc.) is not detailed in this summary.
Data Provenance: Not specified. The tests were performed to demonstrate substantial equivalence, likely at Zest Anchors, LLC or a contracted lab. The country of origin and whether it was retrospective or prospective is not applicable as these were lab-based performance tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission is for a material (dental composite) and relies on objective, standardized physical/chemical property testing (e.g., flexural strength, water sorption) rather than expert interpretation of data or images to establish a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3. This device does not involve human interpretation or subjective judgment on a test set that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a dental material, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental material. There is no algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Objective Material Property Standards: The "ground truth" or reference for evaluating this device's performance relies on established physical and chemical property standards from ISO (e.g., ISO 20795-1, ISO 4049) for comparable dental materials. The performance metrics themselves (e.g., specific flexural strength values) are the "truth" against which the device is measured to demonstrate substantial equivalence to predicates.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a material, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this type of device.

Summary

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JUN 1 6 2014

Chairside® Attachment Processing Material K140570

510(k) Summary

Zest Anchors, LLC

Chairside® Attachment Processing Material K140570

June 3, 2014

ADMINISTRATIVE INFORMATION

Manufacturer Name

Official Contact

Representative/Consultant

Zest Anchors, LLC 2061 Wineridge Place Escondido, CA 92029 +1 (760) 743-7744 ext. 140 Telephone: +1 (760) 743-7975 Fax:

Annie Wright Regulatory Affairs Manager

Kevin A. Thomas, Ph.D. Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 +1 (858) 792-1235 Telephone: +1 (858) 792-1236 Fax: kthomas@paxmed.com Email: flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name Common Name

Classification Name Classification Regulations Product Code

Classification Panel Reviewing Branch

Chairside® Attachment Processing Material Resin, denture, relining, repairing, rebasing

Denture relining, repairing, or rebasing resin Class II, 21 CFR 872.3760 EBI

Dental Products Panel Dental Devices Branch

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INTENDED USE

Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent to the following predicate devices:

. VOCO GmbH, Quick Up (K110440)
IMTEC Corporation, SECURE (K021586) .
Danville Materials, Inc., Starfill 2B HV, Starfill 2B LV (K092912) ●
DMG USA, Inc., Flowable Composite (K011211) .

The subject device, Chairside Attachment Processing Material, has a similar formula to the device cleared in K092912. The subject device is both self-curing and UV-light curing similar to those cleared in K110440, K021586, and K092912. The application of the subject device is similar to those cleared in K110440, K021586, and K092912. The intended use of the subject device is similar to those cleared in K110440, K021586, and K011211.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included performance testing. Performance testing to demonstrate substantial equivalence included methods described in the standards ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers and ISO 4049 Dentistry - Polymer-based restorative materials. The following testing was performed:

Flexural strength per ISO 20795-1 :
Flexural modulus per ISO 20795-1 .
Water Sorption per ISO 4049 .
Water Solubility per ISO 4049 .

Clinical data were not submitted in this premarket notification.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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Overall, Chairside Attachment Processing Material has the following similarities to the predicate devices:

has the same intended use, .
. uses the same operating principle,
incorporates the same basic design, ●
incorporates the same or very similar materials, and .
has similar packaging. .

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 19903 New Hampshire Avenue Document Control Center - WO66-Ci60 Silver Spring, MD 20993-0002

June 16, 2014

Zest Anchors, LLC c/o Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K140570

Trade/Device Name: Chairside® Attachment Processing Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: April 10, 2014 Received: April 11, 2014

Dear Dr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Thomas

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

MaryStibner-s

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Chairside® Attachment Processing Material

510(k) Summary

Indications for Use

K140570 510(k) Number:

Chairside® Attachment Processing Material Device Name:

Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Sheena A. Green
2014.06.13 08:00:12-04:00

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.